CITI Training for Human Subjects Research

Group 1: Biomedical research Investigators and Key Personnel - Basic Course. This course is required for medical, physiological or pharmacological studies that includes, but is not limited to, research with drugs, devices or other interventions.(Researchers collaborating with Baystate should complete all modules to be certified for Baystate Collaborative Studies.); or

Group 2: Social Behavioral and Education Research Investigators and Key Personnel - Basic Course. This courseis required for studies on sociological, psychological, anthropological or educational phenomenaincluding observational and survey research and work with population and/or epidemiological studies..

Please select the group that best corresponds to the nature of your research. Completion of the CITI training is required prior to issuing aneProtocol login. You must receive a score of 80% or better overall in order to pass this course. If you receive less than 80% you will need to retake one or more quizzes to improve your score to 80% overall.

PLEASE NOTE: The Social and Behavioral Responsible Conduct of Research and the BiomedicalResponsible Conduct of Research courses do NOT satisfy the human subjects training requirement.

Refresher Training

All human subjects researchers at UMass are required to complete a CITI Training refresher every 5 years. If CITI training is expired (over 5 years) IRB submissions such as new studies, revisions, renewals will not be processed until the CITI refresher has been completed.

1. Select Log In.
2. Select "Log in through my Institution."
3. Scroll and click on "University of Massachusetts Amherst."
4. At the UMass NetID login screen enter your campus-wide NetID credentials.
5. On the Main Menu page, click on "University of Massachusetts Amherst Courses."
6. Under "My Learner Tools for University of Massachusetts Amherst" click on "Add a Course."
7. Scroll Down to Question 1 - Human Subjects Research and choose either "Group 1: Biomedical Research Investigators and Key Personnel" OR "Group 2: Social and Behavioral Research Investigators and Key Personnel."
8. The rest of the courses (#2-8) are not required for Human Subjects research. Please note that you have to answer each question in order to move on to your selected course.

*PLEASE NOTE: The Social and Behavioral Responsible Conduct of Research and the Biomedical Responsible Conduct of Research course do NOT satisfy the human subjects training requirement.

*******************************************************************NOTE: You do not need to complete the course in just one session. You are encouraged to use several "log-on" sessions, but you should take the quizzes immediately after completing each module.

When you have completed all requirements, you will be able to download your Certificate. Under the column "Completion Record" click on "View-Print-Share" for further instructions.

CITI Training Module Requirements

Investigators, including faculty, staff, and students, directly involved in research with human subjects are required to complete an education program in human subjects protection. Completion of required CITI training modules listed below fulfills the UMass requirements for investigator training (NOTE: Investigators taking the training for the first time must take the CITI training basic course. Investigators whose CITI training was first completed over 5 years ago must take the refresher course):

From your main menu click on the link "Affiliate with another institution."

Choose the correct institution from the appropriate drop down menu.

Answer the member information questions required by your newly affiliated institution.
*Please note that you do not need to provide a UMass email address in the field marked “Institutional email address” if you don’t have one - you can provide any valid email address.

Enroll in the course(s) required by your newly affiliated institution.

If you would like to receive credit for modules previously taken, consider the following:

You must choose the same course at both institutions (i.e., Group 1 Basic/same - Biomedical Basic/same - Group 2 Refresher/same) in order to get credit. You will receive automatic credit for any modules duplicated. The modules must be identified as the same module by the unique modules ID number. Because each institution determines which modules are available in their courses not all modules will transfer.

Each institution determines the time frame in which modules are transferable. This time frame can be between 1 and 10 years. Some institutions opt off of this option and do not allow modules to transfer.

Who Is Considered Key Study Personnel on a Protocol?

The following information is intended to help researchers determine who is to be included on a protocol involving human subjects. This information is also related to the mandatory training requirement that the UMass Amherst has for involvement in human subjects protection.

A person listed as key study personnel in the IRB application is an individual who is interacting and/or intervening with human subjects or handles the personally identifiable data of a human subject.

Study personnel that are involved in the informed consent process should also be included on the IRB study personnel list.

Addition of new key study personnel to an IRB approved protocol will only be approved if the proposed study personnel have completed the required CITI training. Please note that funding agencies may have their own definition of study personnel as it applies to grant or other funding applications.

Optional CITI Training Module(s)

For those engaging in international human subjects research, CITI has developed new modules that are optional but may be useful to your research. The international modules can be found by linking to "International Course Site" located in the tabs across the top of the CITI Training Website. (Note: The international modules are not a substitute for the requirement to take either Group 1 or Group 2 mentioned above.)